{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-04-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "country": "United States",
      "city": "Ocala",
      "address_1": "1210 SW 33rd Avenue",
      "reason_for_recall": "Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.",
      "address_2": "",
      "product_quantity": "72 units",
      "code_info": "Rx #'s:  0389464    0398833    0399748    0402917    0402926    0405892    0404079    0404086    0392875    0398067    0403137    0403795    0404506    0408694    0404895    0387492    0389813    0390461    0391264    0391818    0391961    0392952    0393766    0395543    0396232    0396925    0397181    0397313    0397959    0399219    0400227    0400749    0400845    0401497    0401998    0402465    0402997    0403162    0405298    0405330    0405341    0406903    0407419    0408021    0409309    0409791    0402406    0402414    0389982    0389976    0407175    0386101    0391782    0394584    0399576    0403154    0403358    0404795    0406532    0409701    0410127    0400234    0389894      0369509    0407537    0387936    0388504      0401671    0391774    0395019",
      "center_classification_date": "20120810",
      "distribution_pattern": "Nationwide, Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, and West Indies",
      "state": "FL",
      "product_description": "ESTRADIOL 25MG PELLETS 1 PELLET, 15 PEL, 15 PELLET, 2 PELLET, 2 TAB, 3 PELLET, 4 PELLET, 6 PELL, 6 PELLET; ESTRADIOL 50MG PELLETS 1 PELELT, 1 PELLET, 4 PELLET, 6 PELLET; ESTRADIOL CYPIONATE 5MG/ML INJECTABLE 5 ML; ESTRADIOL VALERATE IN COTTONSEED OIL 40 MG/ML INJECTABLE 10 ML; ESTRADIOL VALERATE IN SESAME OIL 40 MG/ML INJECTABLE 10 ML (16 DIFFERENT PRODUCTS)",
      "report_date": "20120822",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Franck's Lab Inc., d.b.a. Franck's Compounding Lab",
      "recall_number": "D-1515-2012",
      "initial_firm_notification": "Letter",
      "product_type": "Drugs",
      "event_id": "62416",
      "termination_date": "20140813",
      "more_code_info": "",
      "recall_initiation_date": "20120525",
      "postal_code": "34474-5138",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}